To say that 2023 continued to be a difficult fundraising environment for companies in Europe is an understatement. However, there were some green shoots and investors continued to back companies, seeing opportunities across the health tech, med-tech and biotech space.
The med-tech industry had high hopes in 2023 regarding Medicare coverage for breakthrough medical devices, but those hopes were dashed when the U.S. Centers for Medicare & Medicaid Services (CMS) withdrew the associated draft rule and will instead issue a “notice” regarding the Transitional Coverage for Emerging Technologies (TCET) concept.
In his latest effort to boost the U.S. manufacturing base, President Joe Biden is invoking the Defense Production Act (DPA) to expand the domestic production capabilities for essential medicines, medical countermeasures (MCMs) and their critical inputs.
Nearing the end of 2023, South Korea’s National Assembly approved hiked-up budgets for three of its major health care agencies. Its health policy think tank also forecast an uptick in industry exports in 2024.
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Alpha Source Group, Mediwound, Microbot, Mimedx, Probo Medical, Sequana Medical.
Med-tech firms raising money in public or private financings, including: Bluejay Diagnostics, Median Technologies, Meihua International Medical Technologies, Profound Medical.
Natera Inc., said it has won a preliminary injunction against Neogenomics Inc., which halts any distribution of the latter’s RaDaR (Residual Disease and Recurrence) assay for detection of residual cancer DNA. The matter is anything but closed, and Neogenomics stated that it will appeal the decision, suggesting that this dispute will roll into and play out through much of 2024.
Most categories of med-tech financings peaked during the COVID-19 pandemic, with the highest values seen in 2020-2021. While public/other and private financings have successfully rebounded to pre-pandemic levels, the aggregate financings for 2023 hit an unprecedented low according to BioWorld’s records.
Regulation of medical devices is always a messy and complicated task, but that has proven to be particularly true of the European Union’s (EU) Medical Device Regulation (MDR). Thanks largely to problems with the capacity of notified bodies (NBs) to review renewals of existing CE marks, patients in the EU may experience a significant dearth of medical devices over the next couple of years, a nightmare scenario that has all stakeholders scrambling for solutions.
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